Table 2.
Hazard analysis form for assembly process of reusable medical devices.
| Assembly process | Identification of hazards occurred, controlled or increased in the step | Were potential hazards significant? | Possible causes of potential hazards | Control measures | Was the step a critical control point? |
|---|---|---|---|---|---|
| Material preparation | Insufficient number of dressings and consumables | No | The assembly personnel were unfamiliar with the requirements for quantity of dressings and consumables in device packages | The dressing checklists for device packages were formulated | No |
| Device inspections | Quality defects or quantity errors in devices were not identified | Yes | Poor learning abilities in general workers | ① Fixed general workers were arranged for fixed job positions; ② general workers were assigned to different job positions according to their learning abilities; ③ specific personnel were arranged to regularly organize training and assessment for general workers | Yes |
| Device assembly | Device assembly did not meet the requirements | No | Imperfect work rules | ① The inspection rules was improved with a two-person checking approach being established; ② specific assembly procedures were formulated for packages containing special and complex devices; ③ the reward and punishment systems for assembly personnel were improved | Yes |
| Device placement | Device placement did not meet the requirements | No | Many types of device packages | ① Device packaging checklists were standardized; ② the illustration diagrams of device packages were uploaded to the traceability system; ③ a specific person was arranged to receive new devices; ④ information concerning specifications and model numbers of devices were added; ⑤ more training was provided for the CSSD staff | Yes |
| Inspections of dressings and consumables | Quantity errors or quality defects were not identified | Yes | The dressings supplied by the manufacturers failed the quality inspection | The quality acceptance inspections for dressings were strictly implemented | No |
| Placement of dressings and consumables | Placement errors | No | The placement did not meet the requirements | The flow charts of the proposed placement methods for dressings and consumables were formulated | No |
| Inspection after assembly | Quality defects or quantity errors were not identified | Yes | Unreasonable setting of job positions; heavy workload in inspection | ① Positions with a heavy workload in packaging was split; ② position setting was optimized; ③ the number of inspection personnel was increased | Yes |